Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial

Liang-Cheng Chen, Wen-Yen Chiou, Hon-Yi Lin, Moon-Sing Lee, Yuan-Chen Lo, Li-Wen Huang, Chun-Ming Chang, Tsung-Hsing Hung, Chih-Wen Lin, Kuo-Chih Tseng, Dai-Wei Liu, Feng-Chun Hsu, Shih-Kai Hung, Liang-Cheng Chen, Wen-Yen Chiou, Hon-Yi Lin, Moon-Sing Lee, Yuan-Chen Lo, Li-Wen Huang, Chun-Ming Chang, Tsung-Hsing Hung, Chih-Wen Lin, Kuo-Chih Tseng, Dai-Wei Liu, Feng-Chun Hsu, Shih-Kai Hung

Abstract

Background: Hepatocellular carcinoma (HCC) accounts for 75-85% of primary liver cancers and is prevalent in the Asia-Pacific region. Till now, trans-arterial chemoembolization (TACE) is still one of common modalities in managing unresectable intermediate-stage HCC. However, post-TACE residual viable HCC is not uncommon, resulting in unsatisfied overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been suggested to manage HCC curatively. However, evidence from phase-III trials is largely lacking. Hence, the present phase III randomized trial is designed to compare clinical outcomes between SABR and re-TACE for unresectable HCC patients who had incomplete response after initial TACE.

Methods: The present study is an open-label, parallel, randomized controlled trial. A total of 120 patients will be included into two study groups, i.e., SABR and re-TACE, with a 1:1 allocation rate. A 3-year allocating period is planned. Patients with incomplete response after initial TACE will be enrolled and randomized. The primary endpoint is 1-year freedom-form-local-progression rate. Secondary endpoints are disease-progression-free survival, overall survival, local control, response rate, toxicity, and duration of response of the treated tumor.

Discussion: SABR has been reported as an effective modality in managing intermediate-stage HCC patients, but evidence from phase-III randomized trials is largely lacking. As a result, conducting randomized trials to demarcate the role of SABR in these patients is warranted, especially in the Asia-Pacific region, where HBV- and HCV-related HCCs are prevalent.

Trial registration: Before enrolling participants, the present study was registered prospectively on ClinicalTrials.gov (trial identifier, NCT02921139 ) on Sep. 29, 2016. This study is ongoing.

Keywords: Hepatocellular carcinoma (HCC); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Trans-arterial chemoembolization (TACE).

Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

The present study will be conducted after a formal approval of Institute Review Board (Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medication Foundation; approval number: A10502001). Important protocol modifications, e.g., changes to eligibility criteria or outcome analyses, will be re-submitted to IRB and implemented only after a re-approval of IRB. All participants will provide informed written consent before their entry into the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The study flow chart. Abbreviation: TACE, trans-arterial chemoembolization; SABR, stereotactic ablative radiotherapy; CT, computed tomography; MRI, magnetic resonance imaging. Note: The randomization will be conducted by using block-stratified method, intending to balance the patient number between groups

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